Postoperative Pain and Healing in Teeth Treated With GentleWave or EndoActivator

Saint Louis University (SLU)

Status: Completed

Conditions: Apical Periodontitis; Symptomatic Irreversible Pulpitis

Treatments: Device: Multisonic vs Sonic activation of irrigants

Study type: Interventional

Funder types: Other

Identifiers

NCT04552132

31359

Details and patient eligibility

About

Patients with painful molars will be randomly assigned to 2 different groups: GentleWave and EndoActivator. The root canals will be completed using identical protocols except in the mode of delivery and activation of irrigation (using either the GentleWave or EndoActivator). Postoperative pain and pain pill consumption will be measured for the 4 days following their root canal using a Visual Analog Scale and Pain Pill Log, respectively. The alternative hypothesis is that patients undergoing treatment using the GentleWave will experience less pain postoperatively and will consume fewer pain pills.

A 12-month follow up with exam and radiographs will be completed to evaluate healing.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults, able to provide informed consent, with restorable symptomatic molars reporting preoperative pain ≥20mm on a 100mm Visual Analog Scale (VAS) during the previous 24 hours.

Exclusion criteria

• Minors
• Pregnant women
• Prisoners
• Persons unable to adequately provide informed consent
• Non-restorable teeth
• Patients unable to sit in the dental chair for 3 hours
• Patients with compromised cardiac health requiring less than .08mg epinephrine
• Patients with a pacemaker
• Patients where Ibuprofen and Acetaminophen are contraindicated
• Patients unable to swallow pills
• Patients with pain originating somewhere other than the tooth in question
• Patients having taken analgesics within previous 6 hours

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

GentleWave

Experimental group

Description:

Patients randomly assigned to the GentleWave group will receive irrigation and activation of irrigants with the GentleWave device (multisonic energy) by Sonendo.

Treatment:

Device: Multisonic vs Sonic activation of irrigants

EndoActivator

Active Comparator group

Description:

Patients randomly assigned to the EndoActivator group will receive irrigation via a side-vented needle and activation using the EndoActivator (sonic energy) by Dentsply Sirona.

Treatment:

Device: Multisonic vs Sonic activation of irrigants